FDA批准第三款新冠疫苗紧急使用授权(美国美中報導)

2月28日,美国食品药品管理局(FDA)对第三款用于预防严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的疫苗颁发了紧急使用授权。该紧急使用授权允许强生旗下的杨森制药公司生产的新冠疫苗在美国分发并用于十八岁(含)以上人群。

“本着疫情事态紧急之需,通过我们公开透明的科学评估过程,基于我们支持紧急使用授权所需的严格的安全、效果和生产质量标准,FDA现已批准三款新冠疫苗的紧急使用授权。” FDA代理局长医学博士珍妮特·伍德考克说。

杨森的新冠疫苗为单剂量疫苗。总体而言,对于预防中重度新冠肺炎,该疫苗在接种至少14天后产生保护效力约为67%,接种至少28天后保护效力约为66%。

此外,对于预防重度新冠肺炎,该疫苗在接种至少14天后产生的保护效力约为77%,接种至少28天后保护效力约为85%。

详情请见:https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

On Feb 28, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of COVID-19 caused by SARS-CoV-2. The EUA allows the Janssen COVID-19(Johnson & Johnson)  Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

“The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.” said Acting FDA Commissioner Janet Woodcock, M.D.

The Janssen COVID-19 Vaccine is administered as a single dose. Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

More info: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

分享: